Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer

Lung Cancer Clinical Trial

Official title:

Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833205
• Other study ID #: BH005
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2021
• Est. completion date: April 19, 2023

Study information

• Verified date: April 2021
• Source: Hebei Medical University
• Contact: hui bu, PhD
• Phone: 0311-66003711-211
• Email: buhuimy1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 years or older, gender not limited;
• A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging;
• Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis
• Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage
• Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression
• Bone marrow, liver, kidneys and blood clotting function are relatively stable

Exclusion Criteria:

• Eastern Cooperative Oncology Group scored > 2 points
• Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study

Related Conditions & MeSH terms

• Leptomeningeal Metastasis
• Lung Cancer
• Lung Neoplasms
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• Nimotuzumab
Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks

Locations

Country	Name	City	State
China	The Second Hospital of Hebei Medical University	Hebei	Shijiazhuang/hebei
China	The Second Hospital of Hebei Medical University	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hui Bu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	From the diagnosis of the LM to the time of disease worsen	2 years
Secondary	Overall Survival	From the diagnosis of theLM to the time of death	2 years
Secondary	Incidence of Treatment-Emergent Adverse Events	When the Nimotuzumab is used,we will observe if the patients have the allergic reaction,diarrhea ,vomiting and so on.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"	8Weeks